Regulatory Requirements

 

from ed istockphoto heart and heartbeat Regulatory Requirements

At Present the Food and Drug Association (FDA) and the International Conference on Harmonisation (ICH) have not issued any final standards concerning the use and submission of Digital ECG data for cardiac safety in clinical research; however as detailed in the “The Clinical Evaluation of QT Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs” published in November 2002 which was sponsored by DIA, in collaboration with NASPE, FDA, and Health Canada and its recent review/revision in the ICH process in June 2004:

  • ECGs should be recorded and stored as a digital signal
  • ECGs should be annotated and submitted in a digital format
  • All ECG measurements should be performed manually using digitised methods
  • All ECG over reads should be peformed from centralised laboratory

Overall, this new regulatory guidance requires a more uniform and robust approach to cardiac safety assessments in order to ensure patient safety before drugs are approved for the market. With the prescience of QT affects now the most common cause of all new drug withdrawal, delay or incomplete lack of regulatory approval, accurate and effective QT interval measurement and analysis is clearly a fundamental requirement in the development of any new pharmaceutical agent.

Express Diagnostics recognizes that with such developments our customers will be looking to us to provide not only the technical expertise that they have come to rely on but also the support and flexibility to accommodate their ever changing needs, allowing them to comply fully with any requirement that the regulatory authorities adopt concerning Digital ECG data delivery. All Express Diagnostics systems and devices are 21 CFR Part 11 compliant and use fully validated software. We strictly adhere to Good Clinical Practices (GCP)

21 CFR Part 11

21 CFR Part 11 applies when using a computer system to create, modify, transfer or store any electronic representation of information or process that is regulated by the Food and Drug Administration (FDA). In light of this, Express Diagnostics have been working closely with external consultants to fully assess all our processes and systems to achieve the current position of inspection readiness.

Express Diagnostics recognizes that 21 CFR Part 11 is dynamic in nature and as such, requires ongoing attention in order to maintain a position of inspection readiness. We also understand that interpretations of this regulation may differ from company to company and are therefore constantly reviewing our current position and understanding, whilst continuing to build our 21 CFR Part 11 portfolio.

ICH E14 Document PDF